Status:
COMPLETED
Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
The Cleveland Clinic
Biofrontera Inc.
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment times will still be effective at treating actinic keratoses (AK) while reducing or eliminating the pain that p...
Eligibility Criteria
Inclusion
- Minimum of 10 actinic keratoses lesions on the face.
- Female subjects must not become pregnant during the study
- Subjects must be able to understand and willing to sign a written informed consent document.
Exclusion
- Pregnant or nursing.
- Using any topical treatment on their AKs; must stop at least one month prior.
- Currently undergoing treatment for other cancers with medical or radiation therapy.
- Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material.
- Patients with history of a photosensitivity disease, such as porphyria cutanea tarda.
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06027619
Start Date
October 2 2023
End Date
July 8 2024
Last Update
October 23 2025
Active Locations (1)
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1
Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195